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Regulatory Affairs - API ( Jr. Executive/Executive/Sr. Executive )

2 - 7 years

3 - 7 Lacs

Posted:Just now| Platform: Naukri logo

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Full Time

Job Description

Roles and Responsibilities Prepare dossiers for regulatory submissions, including variations, renewals, and rejections. Review DMFs, CMCs, USDMFs, ASMFs, EDQMs, LOAs, QMS documents for accuracy and compliance with regulations. Coordinate with internal teams to gather necessary information for regulatory submissions. Ensure timely submission of applications to relevant authorities in various markets (US, Europe). Maintain records of all submitted documents and follow up on their status.

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200+ Employees

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    Key People

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  • Mr. Gupta H

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